Stable salts of S-adenosyl-L-methionine (SAMe) and the process for their preparation

Abstract

This invention relates to the production of new & stable salts of S-adenosyl-L-methionine SAMe). The source of SAMe used in the salt formation is from chemical process wherein stereoselective methylation of S-adenosyl-L-homocysteine is achieved. The process for the salt preparation is simple, efficient & reproducible on large scale. The new salts were found to be stable at accelerated temperature for minimum 3 months.

What is claimed is:  
     
       1. A stable salt of S-adenosyl-L-methionine selected from the group consisting of S-adenosyl-L-methionine disulfate resorcinol-4,6-disulfonate, S-adenosyl-L-methionine disulfate catechol-3,5-disulfonate, S-adenosyl-L-methionine disulfate phenol-2,4,6-trisulfonate and a sodium salt thereof. 
     
     
       2. A process for preparing a stable salt of  claim 1 , the process comprising: 
       i) converting S-adenosyl-L-homocysteine into (S-S)-isomer enriched-S-adenosyl-L-methionine;  
       ii) producing S-adenosyl-L-methionine as a S-adenosyl-L-methionine sulfate salt; and  
       iii) converting the S-adenosyl-L-methionine sulfate salt into a S-adenosyl-L-methionine mixed sulfate salt and spray drying it.  
     
     
       3. The process of  claim 2 , wherein the conversion step (iii) is conducted using a sulphonic acid selected from the group consisting of resorcinol-4-6-disulfonic acid, catechol-3,5-disulfonic acid and phenol-2,4,6-trisulfonic acid.